Community-based Approaches to Treating Hypertension and Colon Cancer Prevention (MISTER-B)

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborators:
Cornell University
Wayne State University
Information provided by (Responsible Party):
Joseph E. Ravenell, MD, MS, New York University School of Medicine
ClinicalTrials.gov Identifier:
NCT01092078
First received: March 18, 2010
Last updated: November 12, 2013
Last verified: November 2013

March 18, 2010
November 12, 2013
May 2010
April 2014   (final data collection date for primary outcome measure)
  • Blood Pressure [ Time Frame: Outcome is measured at 6-month follow-up ] [ Designated as safety issue: No ]
    Three blood pressure measures and the average of the three measures will be obtained at baseline and 6-month follow-up using a Welch Allyn Vital Signs automated blood pressure monitor.
  • Colon Cancer Screening Behavior [ Time Frame: The outcome will be measured at 6-month follow-up ] [ Designated as safety issue: No ]
    Whether or not the participant was screened for colon cancer between baseline and 6-month follow-up will be assessed using self-report and patient medical records.
  • Blood Pressure [ Time Frame: Outcome is measured at 6-month follow-up ] [ Designated as safety issue: No ]
    Three blood pressure measures and the average of the three measures will be obtained at baseline and 6-month follow-up using a MicroLife automated blood pressure monitor.
  • Colon Cancer Screening Behavior [ Time Frame: The outcome will be measured at 6-month follow-up ] [ Designated as safety issue: No ]
    Whether or not the participant was screened for colon cancer between baseline and 6-month follow-up will be assessed using self-report and patient medical records.
Complete list of historical versions of study NCT01092078 on ClinicalTrials.gov Archive Site
  • Medication Adherence [ Time Frame: 6-month follow-up ] [ Designated as safety issue: No ]
    Medication adherence will be assessed using the 4-item Morisky Medication Adherence scale.
  • Physical Activity [ Time Frame: 6-month follow-up ] [ Designated as safety issue: No ]
    Physical activity will be measured using the International Physical Activity Questionnaire (IPAQ).
  • Intrinsic Motivation to Exercise [ Time Frame: 6-month Follow-up ] [ Designated as safety issue: No ]
    Intrinsic motivation will be assessed using a 17-item questionnaire.
  • Self-Efficacy (Exercise) [ Time Frame: 6-month follow-up ] [ Designated as safety issue: No ]
    Self-efficacy related to exercise will be measured using a 12-iten questionnaire.
  • Dietary Intake [ Time Frame: 6-month follow-up ] [ Designated as safety issue: No ]
    Dietary intake will be assessed using the Food Frequency Questionnaire.
  • Intrinsic Motivation (Diet) [ Time Frame: 6-month follow-up ] [ Designated as safety issue: No ]
    Intrinsic motivation relating to diet will be assessed using a 17-item scale.
  • Self-efficacy (Diet) [ Time Frame: 6-month follow-up ] [ Designated as safety issue: No ]
    Self-efficacy relating to diet will be assessed using a 10-item scale.
  • Facilitators and Barriers to obtaining a colonoscopy [ Time Frame: 6-month follow-up ] [ Designated as safety issue: No ]
    Facilitators and barriers to obtaining a colonoscopy will be assessed using a self-reported scale.
  • Behavioral Intention relating to colon cancer screening [ Time Frame: 6-month follow-up ] [ Designated as safety issue: No ]
    Behavioral intention to screen for colon cancer will be assessed using a self-reported scale.
  • Social Influence relating to colon cancer screening [ Time Frame: 6-month follow-up ] [ Designated as safety issue: No ]
    Social influence relating to colon cancer screening will be assessed using a self-reported questionnaire.
Same as current
Not Provided
Not Provided
 
Community-based Approaches to Treating Hypertension and Colon Cancer Prevention
Community-based Approaches to Treating Hypertension and Colon Cancer Prevention

Black men constitute the demographic group with the greatest burden of premature death and disability from hypertension (HTN) in the United States. But while the disproportionately high rate of hypertension-related morbidity and mortality is well documented, the epidemic of colorectal cancer (CRC) among black men is comparatively under-appreciated. For example, CRC is a leading cause of cancer death in black men with a death rate 50% higher than in white men. Low rates of screening for CRC in this population contribute significantly to this problem. The purpose of this randomized controlled trial (RCT) is to evaluate the effect of a lifestyle intervention delivered through telephone-based motivational interviewing (MINT) versus a patient navigation intervention on blood pressure reduction and CRC screening.

Not Provided
Interventional
Not Provided
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
  • Hypertension
  • Colon Cancer
  • Behavioral: MINT
    Motivational interviewing for lifestyle changes associated with treating hypertension
  • Behavioral: Patient Navigation
    Patient navigation for colonoscopy.
  • Experimental: Motivational Interviewing
    Individuals in the motivational interviewing (MINT) arm of the study will receive telephone-based lifestyle interviewing for 6-months. Counseling will be aimed at modifying diet and/or physical activity behaviors associated with decreasing blood pressure.
    Intervention: Behavioral: MINT
  • Experimental: Patient Navigation
    Participants in the patient navigation arm will receive patient navigation for colonoscopy.
    Intervention: Behavioral: Patient Navigation
  • Experimental: PLUS
    Both patient navigation for colorectal cancer screening and motivational interviewing for blood pressure control
    Interventions:
    • Behavioral: MINT
    • Behavioral: Patient Navigation
Ravenell J, Thompson H, Cole H, Plumhoff J, Cobb G, Afolabi L, Boutin-Foster C, Wells M, Scott M, Ogedegbe G. A novel community-based study to address disparities in hypertension and colorectal cancer: a study protocol for a randomized control trial. Trials. 2013 Sep 8;14:287. doi: 10.1186/1745-6215-14-287.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
720
May 2014
April 2014   (final data collection date for primary outcome measure)

Inclusion Criteria:

  1. Participants must be age 50 years or older,
  2. Self-identify as a black or African American male,
  3. Have uncontrolled hypertension as defined by systolic blood pressure (SBP) > 135 mmHg or diastolic blood pressure (DBP) > 85 mmHg and SBP > 130 or DBP > 80 mmHg (in those with diabetes at the screening).

Exclusion Criteria:

1. Inability to comply with the study protocol (either self-selected or by indicating during screening that he could not complete all requested tasks).

Male
50 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01092078
09-0151
Yes
Joseph E. Ravenell, MD, MS, New York University School of Medicine
New York University School of Medicine
  • Cornell University
  • Wayne State University
Principal Investigator: Joseph Ravenell, MD, MS NYU School of Medicine
New York University School of Medicine
November 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP